Last Patient Last Visit (LPLV) completed for the Penta 17 Strategy for Maintenance of HIV suppression with integrase inhibitor + darunavir/ritonavir in children (SMILE) trial.
The Penta sponsored trial, SMILE, has completed its last patient last visit. This exciting news comes to us following the closure of patient enrolment for SMILE last year, where all participants recruited were followed up for a minimum of 48 weeks until the last participant enrolled reached 48 weeks of follow-up on 11 August 2020.
This brings the SMILE trial to a close, and is an important milestone for the trial. Our congratulations and thanks go to all the participants and families, the clinicians and sites involved as well as the clinical trial units of the study, INSERM-SC10, MRC-CTU at UCL and PHPT for their collaboration!
SMILE is a multicentre randomised study evaluating safety and antiviral effect of a once daily integrase inhibitor administered with darunavir/ritonavir compared to standard of care among HIV-1 infected, virologically suppressed paediatric participants. Participants from 32 sites spread across 11 countries in Europe, Asia, Africa and South America have taken part in the study. The trial has been funded by Janssen, Gilead and ViiV Healthcare.